Below is a lightly-edited transcript from a live conversation with Lisa Delfini, CFO of Trevi Therapeutics.
Trevi Therapeutics is a clinical-stage biopharmaceutical company based in New Haven, Connecticut, developing a therapy for chronic cough in patients with pulmonary fibrosis and refractory chronic cough. In June 2025, Trevi announced positive topline results from its Phase 2b trial and closed an equity offering with proceeds of approximately $115 million.
Lisa Delfini is the CFO of Trevi Therapeutics, and has been in the role since 2021. She was previously Accounting and Advisory Services Partner at Marcum LLP, and held senior roles at GE, including Global Controller for GE Corporate’s Technical Center of Excellence and Global Controller for the GE Industrial Solutions division. She started her career at Deloitte & Touche LLP, becoming Client Service Partner by the end of her tenure.
Highlights:
Erin Warner Guill (Auxilius): Welcome everybody!
I’m Erin Warner Guill, President and COO of Auxilius. I’ve been here since the beginning and, like Lisa, come from a finance background. I oversee everything on the commercial side of Auxilius.
I’m joined by Lisa Delfini, CFO of Trevi. We’re very excited to have her here. By way of background, Lisa, you’ve been CFO of Trevi since 2021. Before that, you were a Financial Accounting and Advisory Services Partner at Marcum LLP, serving life sciences and tech companies. You also held senior roles at GE, including Global Controller for GE Corporate’s Technical Center of Excellence, and spent 16 years at Deloitte, becoming a Client Service Partner by the end of your time there.
As for Trevi, we’ll talk about the company’s evolution. Trevi Therapeutics is a clinical-stage biopharmaceutical company based in New Haven, Connecticut, developing a therapy for chronic cough in patients with pulmonary fibrosis and refractory chronic cough.
Many of us follow Endpoints and industry headlines, exciting recent developments. Trevi announced positive topline results from its Phase 2b trial of Haduvio for patients with chronic cough related to idiopathic pulmonary fibrosis and recently closed an offering with proceeds of approximately $115 million. We’ll walk through both of those developments because there’s a lot to learn from Lisa’s experience.
So with that, Lisa, from your perspective, let’s start with the industries you’ve worked in. What sets biotech and biopharma apart from a finance perspective?
Lisa Delfini (Trevi Therapeutics): I would say that all of my roles have been fast-moving, very fast-paced. There’s always been a lot of change, no matter where I’ve been.
I think the speed at which biopharma, life sciences, and biotech companies have to pivot is sometimes mind-blowing. We joke that it’s like being on a roller coaster, you can be at the highest of highs one day and the lowest of lows the next. You have to constantly adapt to that.
When I first joined the company, it was a tough time to raise capital and a tough time in general. We were coming off of COVID, and clinical trials were being delayed. Cash was running out for many companies. It was a challenging time, and we were close to not existing for a while. Then we read out positive data and raised $50 million, which really changed the trajectory of the company. To go through that downturn and then raise $115 million just a few weeks ago, on top of the $50 million we raised in December, has been a significant shift.
Navigating that kind of pivot, and everything that comes with it, has been a major part of the journey. In 2021, we weren’t hiring anyone because of uncertainty. Now we’re preparing for the next phase of expansion. That level of volatility and turnaround is what stands out most about the finance role in biotech compared to my previous roles.
Erin: That makes a lot of sense. I think it really highlights the need to stay flexible and open-minded. Every day can look different.
Erin: You and I have talked before about the different “flavors” of CFOs, some come from Wall Street or investment banking, others are more financial or strategic operators. How do you think about your flavor of CFO? Where do you excel, and how does that shape your day-to-day priorities?
Lisa: My background isn’t investment banking, right? I came from audit and financial services, and I held roles in industry before this, including projects at GE that related to its healthcare division. So my background leans more financial and operational. That meant a steep learning curve in this role, especially getting used to meeting with investors frequently and ensuring our messaging communicates an effective company strategy . Our entire team plays a role in that, but it was a big adjustment for me.
Also, the patient focus in this industry is different from anything I’ve done before. Being at Trevi is personally meaningful, my mother passed away from pulmonary fibrosis about a year and a half ago, and she had the chronic cough associated with it. That connection made it easy for me to stay close to the patient journey as I learned about our development pathway. It mirrored what I saw my mom go through.
That’s been very enriching for me. She even came to speak with the Trevi team about her experience, which helped connect the whole company to the voice of the patient, which is important for the company.
Erin: That’s an incredible and powerful message, and we’ve heard that consistently. One thing that always amazes me is how finance and accounting teams across biotech end up knowing more about science than they ever imagined. It’s great to keep both the science and the patient at the core. I really appreciate you sharing that.
Erin: You’ve outlined the financial trajectory, and there’s clearly a lot of exciting progress. I’d love to hear from your perspective, what are your biggest priorities or initiatives your team is focused on at Trevi today?
Lisa: I’d say there are really three:
First is ensuring the company is funded. That starts with all the preparation that goes into a financing, figuring out when the timing is right, preparing materials, investor targeting. And then when we’re in the middle of a deal, it becomes all-consuming for my department because of the volume of transactional work involved.
Second, we need to ensure the clinical development team has the financial information they need to make decisions. That’s the lifeblood of the company, developing the drug. If they’re not successful, then nothing else matters, so we support them as closely as possible.
Third is compliance. That includes SEC filings, financial statements, and internal controls. That’s actually a major focus for me right now, as there’s a potential we’ll need to be SOX 404(b) compliant. That’s a significant undertaking for a company of our size.
So those are the three main areas of focus: fundraising, enabling clinical teams, and staying on top of compliance.
Erin: Those are three great priorities, and real opportunities for impact. I find the second point especially interesting. Lisa, you mentioned it’s your job to help the clinical development team understand what’s happening from a financial perspective. That’s an area where we often see disparity across the industry.
Lisa: Sometimes, finance and accounting teams are so focused on compliance, rightly so, that the role of being a business partner to clinical gets overlooked. Financial accuracy and compliance are essential, of course, but acting as a strategic partner to the clinical team is just as critical.
Erin: When those functions collaborate effectively, I imagine it also makes it easier to gather accurate expense estimates at month-end.
Lisa: Yes, absolutely. We try to be as supportive as possible. In fact, we recently changed our structure, we moved someone from my finance team into the R&D team. She helps with the types of things we were always asking clinical to provide, but that were hard for them to answer. They don’t always “speak accrual,” and sometimes our questions weren’t framed in ways that made sense to them.
That shift has been a game changer. She also works closely on contracts with the clinical development team, since there are always a huge number of contracts in motion. Historically, the ClinOps team handled that, but now we have someone with a finance background who can help crunch the numbers, validate estimates, and triage before things get too far along. That early support makes a big difference.
We try to help however we can. I regularly remind my team that our job is to make life easier for the clinical folks. Their work is incredibly complex. We have GAAP, the SEC, and tons of accounting guidance. But clinical teams are developing drugs without a defined roadmap. There is some FDA guidance, but the process of proving a drug is safe and effective is very dependent on how the mechanism works in the human body so, by definition, you can’t write rules on how to address every situation in drug development.
They face far more uncertainty than we do. That’s why it’s hard, but important, to stay focused on supporting them while also ensuring the financials are right. It’s hard to stay focused that way, but we try.
Erin: You mentioned funding and investor targeting earlier, and I want to shift into your recent raise. We're hearing, and seeing, that 2025 is shaping up to be a year of capital scarcity. Yet Trevi just completed a significant raise, which is impressive. Congratulations. For those joining us, what do you attribute that success to?
Lisa: It’s challenging out there, and I really feel for the many companies struggling to get deals done. A successful fundraise depends on several factors.
Today, investors are much more focused on near-term data readouts. Today its difficult to get funding for very early-stage programs without meaningful data. We're fortunate to be at a compelling point, we’ve had four clinical readouts in the last nine months and are completing a Phase 2b trial. That timing plays in our favor.
You need three core things:
1. A drug that works
2. A disciplined, capital-efficient team that can run development programs and related activities effectively
3. A clear, compelling message patients, physicians and investors can understand
We consistently heard from investors that they appreciate our capital efficiency. But that only works if your team is also disciplined about trial execution, because even great drugs can fail if trials aren’t run well.
We also invest in messaging. Our Chief Commercial Officer articulates our reimbursement and market access strategy. Our CEO and Chief Development Officer engage directly with KOLs and clinicians, then bring those insights back to shape how we communicate with investors.
On top of that, we’re very deliberate in targeting. We work with our banks to identify active funds investing in companies like ours, and we plan 12 months out. We often use the JPMorgan Healthcare Conference season as an anchor point, even if we’re not attending the main JPM event. We ask: who do we need to meet this year? And if we don’t get meetings there, we continue outreach at other conferences.
That structured, ongoing investor engagement means that when we’re ready with data, we already have investors who’ve done the work and are ready to move.
Erin: Switching gears slightly, one of the biggest industry topics in 2025 is the regulatory environment. How is that shaping your role as CFO? What is your team doing to prepare or de-risk?
Lisa: So far, we haven’t experienced delays in our interactions with the FDA. We’ve had engagement over the past few , and timelines have been consistent. That said, we have a strong regulatory leader who’s tracking developments closely, especially within the division responsible for our drug.
While we haven’t seen direct impacts, investors are certainly thinking about potential delays. One thing we heard consistently is that they want to see additional overhead runway, enough cash post-readout to account for any delays, regulatory or otherwise. In our recent raise, we were able to secure that extra cushion, which gives us more flexibility.
Erin: That’s reassuring. I think a lot of people are eager for any signals about how the regulatory landscape is affecting companies.
Erin: Let’s shift to something that hits close to home for us at Auxilius. When you joined Trevi, the company was running on QuickBooks, which, with the right person, can technically work for a public company, but we usually see a broader tech transformation as companies grow.
You’ve since led a full-scale financial transformation, including NetSuite, FloQast, Cube, and Auxilius. What drove that transformation, and why now?
Lisa: To be honest, in 2021 we didn’t set out to do a finance transformation. It happened more organically. We knew the first priority was to get off QuickBooks and onto a system with a more automated control environment. That was the starting point.
From there, it just evolved. As we learned about tools that could make us more efficient or strengthen our controls, we kept going. My team would bring forward suggestions, implement Auxilius, add FloQast, and I supported those moves.
We’ve done even more since. We implemented a new stock option management tool called OptionTrax. This year, we added optical character recognition to automate invoice entry.
So yes, we’ve definitely undergone a transformation, but it came step by step. As we identified systems that helped us work smarter or shore up controls, we moved forward.
Erin: One thing we hear often, especially in biotech, is that clinical development gets most of the funding, as it should. It’s the lifeblood of the organization. But that often means finance and accounting teams are lean and resource-constrained. What I find interesting in finance transformations is the trade-off CFOs and controllers face: implementing new technology takes time, but sticking with the status quo has its own costs. How do you think about that trade-off?
Lisa: With Auxilius specifically, the reporting we were getting from our CRO was not meeting our needs. That led to the discovery of some immaterial errors, errors that might have been preventable, but only with a lot more oversight from our side into how investigator fees were being calculated.
At one point, we considered hiring someone whose job would be building and maintaining a custom investigator fee waterfall from scratch. But then we learned about Auxilius. It turned out to be less expensive than hiring that person, and it was built specifically for this purpose. Why reinvent the wheel when a tailored solution already exists?
As for implementation, I honestly don’t think it slowed us down. NetSuite was probably our most complex rollout, but generally we choose tools that are easier to implement, partly because until recently we didn’t have an internal IT team. We needed platforms that didn’t require deep technical resources.
With most systems we’ve adopted, Auxilius included, the implementation was manageable, and the time investment paid off. These tools helped us move faster than if we had built everything manually or relied on legacy approaches. SaaS platforms have really changed the game.
Erin: That makes a ton of sense.
Across the 85 customers we work with, we see a big difference in C-suite involvement in clinical financial management. From your perspective, what does the CFO’s role look like in this area? How involved are you? What visibility do you want, and what do you think good looks like?
Lisa: I’m very involved with Auxilius, from multiple angles. As we’ve discussed, there are different types of CFOs. I come from an accounting and finance background, not investment banking, so my role is grounded in bringing that experience to bear. I’m deeply involved in forecasting, SOX 404(b) compliance, and financial statement accuracy. And I also engage with investors.
Auxilius, and the other tools we’ve implemented, help us forecast better. That directly supports our capital planning and fundraising efforts. NetSuite and Auxilius both feed into Cube, which is our forecasting tool.
I work with our team every day to ensure that our financials and forecasts are accurate and up to date, and that we’re getting full value from these platforms.
Erin: That’s aligned with what we’re hearing across the industry. And going back to investor sentiment, they want to see 12 months of runway after a data readout, which means they need confidence in your forecast. That starts with confidence in the underlying tools and assumptions.
Lisa: Exactly. Forecasting is everything in this market. And capital efficiency plays right into that.
Erin: Trevi recently used the Auxilius Investigator Reconciliation tool for the first time. Lisa, can you walk us through the decision to do that and the downstream impact it’s had, especially on the bottom line?
Lisa: Sure. We had done an abbreviated version of the investigator reconciliation process manually on a prior trial, and we identified duplicate payments. So we knew there was a high likelihood we’d find similar issues again.
The Auxilius tool takes that process further. It doesn’t just catch duplicates, it also flags payments that are inconsistent with the contract or otherwise inappropriate. That level of review wasn’t something we could do effectively with our internal team.
We knew going in that there would probably be value uncovered, and that’s exactly what happened. The benefit we got from using Auxilius significantly exceeded the cost of the tool. And from our perspective, every dollar we can redirect toward the science is a win. That’s the goal, get more capital back to R&D.
Erin: That’s great to hear, and I love that this was on your radar as a CFO. One thing we hear across the industry is that CRO payments aren’t necessarily unchecked, but there's just so much data. Automating the reconciliation process gives teams the ability to confirm payments and bring much-needed transparency, which ultimately helps protect the bottom line.
Lisa: Exactly.
Erin: One last question on Auxilius. You mentioned your initial decision was between hiring a new FTE or adopting software. When you made that decision, this category, clinical trial accruals software, was still emerging. It’s a highly regulated area, and this impacts your financials directly. What gave you comfort as an early adopter?
Lisa: A big factor was risk. Clinical trial accruals are our most significant financial risk. They are a critical audit matter in our audit opinion. That alone was a major driver.
The other piece was seeing the demo. Auxilius is such a niche product, designed specifically for what we needed. My team saw that it could handle direct expenses, pass-throughs, and investigator fees, pulling from EDC data in real time.
One of our biggest pain points was the lag between when patient visits occurred and when we received invoices, often five to seven months later. No matter how hard we tried to impress upon our CRO that we needed to accrue for things when they happened, it just didn’t seem to be a part of their DNA. With Auxilius, we saw it could align accruals with actual activity, and that gave us confidence.
Erin: And with SOX 404(b) potentially on the horizon, how do you see Auxilius helping meet those control requirements?
Lisa: It starts with SOC 1 controls, Auxilius provides a control report we can rely on, and we also document complementary internal controls around it. It’s another tool in our control environment that we need to get our auditors comfortable with.
But the automation and structure Auxilius brings really enhances our process. I’ve told our auditors: this is the best-in-class approach for clinical trial accruals. If we were simply booking based on CRO estimates, we’d lack accuracy. Auxilius helps us get the reporting as accurate as possible, and that strengthens our controls in a big way.
Erin: That makes sense. And I feel like you’re uniquely positioned to appreciate that, given your background.
Erin: A lot of people on today’s call are in accounting manager or controller roles. When you think about the path from preparing monthly close entries to eventually becoming a CFO, what skills should people focus on? What should they be doing now to prepare for that trajectory?
Lisa: One of the most important things is getting opportunities to present. As CFO, you’re constantly communicating with investors, in both formal and informal settings. Even if they want to hear primarily from the CEO or development team, you need to be ready to step in and deliver the message with confidence.
Earlier in my career at Deloitte and GE, I presented often, at trainings and to business units. That helped me build those muscles. So, seek out presenting opportunities wherever you can. It gets you thinking beyond just the numbers.
Second, be curious about the broader business. You can’t be strategic if your focus never extends beyond account reconciliations. Learn what’s going on in clinical, commercial, regulatory, even if it’s not part of your day-to-day. That cross-functional understanding is key to being a strong CFO.
Erin: Those are great takeaways, and they align with what you said earlier about partnering with clinical ops. Some of the most effective finance teams we’ve seen are the ones who proactively engage with clinical, ask thoughtful questions, and see themselves as collaborators, not just gatekeepers.
Erin: How do you work with IR and PR in your role?
Lisa: IR reports directly to me. PR we have a communications team, though we don’t necessarily call it "PR."
IR supports investor targeting. We're always reviewing analyst reports and evaluating whether the messaging of our strategy is landing as intended. If not, we revise our positioning accordingly.
The communications team drafts non-financial sections of press releases, external messaging, and our corporate deck. That function rolls up under our Chief Commercial Officer, but the whole executive team, myself, the CEO, Chief Development Officer, Chief Commercial Officer, VP Regulatory, review most publications. Each of us guides the comms team based on our expertise: I focus on financial content, our CDO and VP Regulatory cover trial design and results, our CCO handles commercial and reimbursement strategy, and the CEO ensures the overall strategic narrative holds together.
Erin: Follow-up: What do you outsource on the IR and PR front?
Lisa: We outsource logistics like press release distribution (e.g., PR Newswire). We also work with an IR firm primarily for two things:
1. Planning for the JPMorgan conference. We don’t attend JPMorgan itself, but we go to a nearby event run by our IR firm, which is excellent. They help us with investor targeting, meeting scheduling, and general prep.
2. Investor introductions. They have strong relationships with funds, HNW individuals, and retail investors, and they arrange meetings for us.
They also review certain communications, though our internal team does most of the heavy lifting.
Erin: Next question, How is Trevi thinking about commercialization? Do you have a built-out BD or commercial team?
Lisa: Not yet. We do have a Chief Commercial Officer, and he has a strategy in place. We’ve developed a plan that allows us to commercialize independently if needed.
Our target indications, idiopathic pulmonary fibrosis and refractory chronic cough, are sizable, but our go-to-market strategy allows us to focus narrowly. Because the drug could be prescribed by specialty pulmonologists and allergists, we can start with a targeted sales force, about 30 to 40 people.
That commercial build-out is still a couple of years away, but we expect things to start ramping up in the next 12-24 months.
Erin: Final question from the chat, do you use Auxilius to forecast clinical expenses?
Lisa: Yes, 100%. Auxilius feeds directly into our FP&A tool, Cube. One of the major benefits is the ability to move from high-level forecasting to more precise estimates.
Erin: That’s exactly why we built forecasting capabilities into Auxilius. General-purpose tools like Cube are fantastic, but they don’t have clinical context. Our forecasting models account for site activation, patient enrollment, and study-specific timelines, which are critical drivers of cost. That’s where we complement general finance systems really well.
Thanks again, everyone. Lisa, congratulations on a great year, and thank you for the thoughtful conversation.
Lisa: Thank you and it was a pleasure talking with you all.
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